FDA approves spinal cord stimulation system for diabetic pain

The FDA has approved the Proclaim XR spinal cord stimulation system to treat painful diabetic peripheral neuropathy, manufacturer Abbott announced in a press release.

The Proclaim XR spinal cord stimulation (SCS) system can provide relief to patients with diabetic peripheral neuropathy (DPN) in need of alternatives to traditional approaches, such as oral medication.

About 34.2 million Americans, or 10.5% of the U.S. population, have diabetes, the release stated. Approximately 50% of adults with diabetes will develop peripheral neuropathy, which may include pain and numbness in the legs, feet and hands.

“Diabetic peripheral neuropathy has long plagued people affected by type 1 and type 2 diabetes, often adding another area of disease management on top of their ongoing monitoring of their glucose levels to manage this challenging disease,” Jason E. Pope, MD, DABPM, FIPP, president of Evolve Restorative Center in Santa Rosa, California, said in the release.

The Proclaim XR SCS system was approved for chronic pain in 2019 and will now offer patients with DPN relief from chronic pain by delivering low doses of stimulation. Battery power in the low-dose setting will last up to 10 years, according to Abbott.

Patients will need to undergo a minimally invasive trial to receive an implant of the Proclaim XR SCS system, which will allow them to control their therapy through an Apple device, the company stated.

“As a leader in diabetes care, Abbott is intimately familiar with the challenges people with diabetes encounter daily,” Pedro Malha, vice president of neuromodulation at Abbott, said in the release. “This new indication for Proclaim XR will drive meaningful change in the treatment of pain associated with diabetic peripheral neuropathy and will be an important tool for physicians and patients in managing this debilitating condition.